ASTM International - ASTM F1984-99(2003)

Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials

historical
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Organization: ASTM International
Publication Date: 1 November 2003
Status: historical
Page Count: 5
ICS Code (Medical equipment in general): 11.040.01
significance And Use:

Inappropriate activation of complement by blood-contacting medical devices may have serious acute or chronic effects on the host. This practice is useful as a simple, inexpensive screening method... View More

scope:

1.1 This practice provides a protocol for rapid, in vitro screening for whole complement activating properties of solid materials used in the fabrication of medical devices that will contact blood.

1.2 This practice is intended to evaluate the acute in vitro whole complement activating properties of solid materials intended for use in contact with blood. For this practice, the words "serum" and "complement" are used interchangeably (most biological supply houses use these words synonymously in reference to serum used as a source of complement).

1.3 This practice consists of two procedural parts. Procedure A describes exposure of solid materials to a standard lot of human serum, using a 0.1-mL serum/13 x 100-mm disposable test tube. Cellulose acetate powders and fibers are used as examples of test materials. Procedure B describes assaying the exposed serum for significant functional whole complement depletion as compared to control samples.

1.4 This practice does not address function, elaboration, or depletion of individual complement components, nor does it address the use of plasma as a source of complement.

1.5 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F 748 may provide guidance for the selection of appropriate methods for testing materials for other aspects of biocompatibility.

Document History

February 1, 2018
Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
1.1 This practice provides a protocol for rapid, in vitro screening for whole complement activating properties of solid materials used in the fabrication of medical devices that will contact blood....
December 1, 2013
Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
5.1 Inappropriate activation of complement by blood-contacting medical devices may have serious acute or chronic effects on the host. This practice is useful as a simple, inexpensive screening method...
August 1, 2008
Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
1.1 This practice provides a protocol for rapid, in vitro screening for whole complement activating properties of solid materials used in the fabrication of medical devices that will contact blood....
ASTM F1984-99(2003)
November 1, 2003
Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
Inappropriate activation of complement by blood-contacting medical devices may have serious acute or chronic effects on the host. This practice is useful as a simple, inexpensive screening method for...
June 10, 1999
Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
1.1 This practice provides a protocol for rapid, in vitro screening for whole complement activating properties of solid materials used in the fabrication of medical devices that will contact blood....
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